Medical and Regulatory Affairs

Consulting

Beware of Underestimating the Value of a Pre-NDA Meeting

Drug development is a resource-intensive endeavor. Seeking input from the U.S. Food and Drug Administration throughout the journey can help optimize those resources and maximize the likelihood of regulatory approval. When preparing to submit a new drug application (NDA), a pre-NDA meeting with the FDA can be a critical step in ensuring the submission of...

Clinical Research: Phase 1 - Phase 4

Adaptive Design Methods Offer Rapid, Seamless Transition Between Studies

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers , each with a unique implication for patient management and therapy....

Medical and Regulatory Affairs

Speed vs Safety: How Regulators Are Sizing Up Evidence Today

In drug development, there is always pressure to move quickly, and with today’s push to develop treatments and vaccines for COVID, those pressures are exacerbated. From sponsors and investors to investigators and regulators, everyone is trying to balance the dual needs for speed and safety. The places where they find success are likely to change...

Clinical Research: Phase 1 - Phase 4

Tumor-Agnostic Treatments: A Game Changer for Rare Oncology Trials

Rare cancers account for almost a quarter of all new cancers worldwide though there is no universally adopted definition for rare cancers. In the U.S., rare cancers are defined as those with fewer than 15 cases per 100,000 per year, whereas in the EU, they are defined as six cases per 100,000 per year. Historically,...

Clinical Research: Phase 1 - Phase 4

Essential Strategies in Dermatology Clinical Trials: The Convergence of Patients, Regulations, and Study Design

Competition for patients among sponsors in the field of dermatology drug development has never been as intense as it is now — so much so that it’s becoming difficult to meet project timelines, attract and retain patients, and achieve comprehensive study results. Patients are in high demand, and making studies appealing to them — convenient,...

Consulting

5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights

A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them. Brief background...

Clinical Research: Phase 1 - Phase 4

A New Era in Dermatology: Study Design, Regulatory Strategies, and Patient Participation

Explore dermatology trials from the vantage point of study design, patient access, data quality, regulatory considerations, and more This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical...

Clinical Research: Phase 1 - Phase 4

PREMIER VOICES #14: Setting a Real-World Strategy in an Evolving Clinical Research Environment

Featured Guests Stacy WeilSenior Vice President,Clinical Data Operations, Strategic Business Optimization Stacy Weil translates Premier Research’s strategy into actionable data initiatives that enable internal and external customers to achieve the highest level of performance and success. Prior to joining Premier Research, Ms. Weil was Vice President of Clinical Data Operations at PatientiP.Read More Nach Davé,...

Medical and Regulatory Affairs

The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One

Between 2010 and 2018, 33.8 percent of the 402 orphan indications approved by the FDA were approved for children only or targeted pediatric diseases.[1] The rare pediatric disease priority review voucher program is one incentive that’s helped to spur research and development in this area with more than 20 vouchers granted to date, but it...

Clinical Research: Phase 1 - Phase 4

PREMIER VOICES #13: Early-Phase Oncology – Emerging From the Crisis & Innovating for the Future

Featured Guests Luke Gill, B.Sc., M.Sc., MBAVice President, Oncology Luke Gill is the head of Oncology Clinical Development Services at Premier Research. He works collaboratively with biotech sponsors, the scientific community, and other stakeholders to develop and implement strategic approaches to early phase oncology development and CAGT trials. As a drug development expert, Gill has...